hematology | oncology
TRANSCRIPT
HEMATOLOGY | ONCOLOGY
HELPING DELIVER LIFE-CHANGING THERAPIES
PROVEN CAPABILITIES TO SUPPORT AND ADVANCE ONCOLOGY RESEARCH• Industry-leading expertise and strategies to
support development of targeted therapies
and cancer immunotherapies
• Translational research approaches, including use
of broad tumor profiles, biomarkers and efficient
adaptive trial designs
• Proven capability to design and operationalize
adaptive and other innovative trial designs
PPD ALSO PROVIDES:
• Deep research experience in solid tumors, hematology,
hematologic malignancies, cancer-related pain and
supportive care
• Access to adult and pediatric hematology/oncology
cooperative study groups and specialty organizations
• Investigator support, development and management
for National Cancer Institute (NCI) proposals
Berry Consultants Partnership
PPD partners with Berry Consultants, a statistical consulting group specializing in the Bayesian approach and adaptive clinical trial design for pharmaceutical and medical device research and development. Together we are able to help clients plan for and effectively realize the benefits of adaptive trial design.
An increasingly competitive marketplace, rising cost pressures and an ever-changing global regulatory environment make it crucial to find a partner who understands the unique complexities and opportunities of this therapeutic area.
THE ADVANTAGE OF PPD’S GLOBAL PRODUCT DEVELOPMENT TEAM
Our global product development team includes
experienced hematologists and oncologists. An
integral part of our medical organization, this group
is comprised of experienced drug development
professionals who work with our clients and clinical
operations team to provide global medical, scientific,
regulatory and product development expertise.
EARLY DEVELOPMENT ONCOLOGY GROUP
Phase I oncology trials are not the same as Phase
I trials in other therapeutic areas. To address the
differences and support the intensive nature of these
studies, we have a dedicated team within hematology/
oncology. Our experts manage the resources
associated with early phase oncology trials to nurture
those trials through completion.
EARLY PHASE ONCOLOGY SITES
PPD has established relationships with a global
group of sites for early oncology development. These
sites achieve excellence in delivery across solid and
hematologic malignancies and varying dose escalation
study designs. These sites combine academic and
non-academic sites with investigators who contribute
expertise in complex study execution and enrollment
in a competitive environment.
More than 14 million cancer diagnoses are made
each year globally,* and worldwide oncology sales are expected to reach $190 billion by 2022.** THE STAKES HAVE NEVER BEEN HIGHER.
*SOURCE: World Health Organization **SOURCE: EvaluatePharma
A CLOSER LOOK AT PPD'S ONCOLOGY EXPERIENCE
Immuno-oncology Center of ExcellencePPD is a leader in immuno-oncology innovation, having conducted more than 120 immuno-oncology programs that include checkpoint inhibitors, immune modulators, monoclonal antibodies, cancer vaccines, adoptive cell therapy and cytokines. Our Immuno-oncology Center
of Excellence is a knowledge center for project teams and clients regarding the competitive environment and efficient adaptive designs and the dynamic regulatory landscape that has evolved with these new and exciting immunotherapies.
A HEMATOLOGY AND ONCOLOGY RESEARCH LEADER
PPD has a broad spectrum of experience managing clinical trials in complex indications such as benign hematologic disorders, hematologic malignancies and oncology diseases, including rare tumor types and supportive care indications in patients with cancer.
Phase I
Phase II
Phase III
Phase IV
Other
PAST FIVE YEARS
98
184
145
11
47
53
127
113
6
11
TOTAL 485
~500 STUDIES
108,000+ PATIENTS
27,000+ SITES
ONCOLOGY CLINICAL EXPERIENCE BY PHASE
GLOBAL310
1,300+ REAL-WORLD AND POST-APPROVAL STUDIES (INCLUDES EVIDERA)
Lung Cancer 10.1%
Hematological Disorders 5.3%
Skin Cancer 8.8%
Breast Cancer 9.8%
Myeloma 6.1%
GI Cancer 8.8%
Lymphomas 6.4%
Leukemia 10.5%
Solid Tumor 17.4%
GU Cancer 7.6%
Other 9.2%
PPD® LABORATORIES: A COMPLETE RANGE OF SOLUTIONS FOR HEMATOLOGY AND ONCOLOGY
Across every phase of pharmaceutical development, clients count on PPD® Laboratories’ services and scientific expertise to deliver the data needed for fast, accurate decision-making.
Our hematology/oncology portfolio covers a wide range of disease mechanisms and targets. Our scientific leaders have extensive hematology/oncology research experience with small molecules, biologics, antibody-drug conjugates (ADCs), biomarkers, cell and gene therapies, and companion diagnostics.
Our strategic alliance with NeoGenomics Laboratories further extends our pathology and molecular capabilities to support complex oncology and immuno-oncology clinical trials.
PPD Laboratories helped develop 19 of the top 20 best-selling oncology drugs of 2018
Vaccine Sciences Lab
EXPANSIVE ARRAY OF LAB SERVICES
Bioanalytical Lab
GMP Lab
Biomarker Lab
Central Lab
Applying Adaptive Trial Design to Hematology and Oncology Trials Adaptive trial design helps ensure potential issues are revealed earlier, enabling faster “go, no-go” decision-making and creating more confidence in outcomes. Adaptive trial design continues to see growing regulatory acceptability from the U.S. Food and
Drug Administration. PPD’s experience in planning and executing adaptive trial designs provides clients significant advantages that lead to safer, faster and more cost-effective outcomes.
Continuous Feasibility and Optimization A feedback loop is used to determine what parts of the trial optimization strategy are successful and what changes are needed to create time and cost savings.
Data-driven Analysis Analytics and expert recommendations improve forecasting to optimize both the protocol and the trial and to mitigate risk before a study begins.
Investigator Feasibility and Site Selection Sites and investigators with experience conducting similar studies and who are proven to recruit patients according to set timelines are recommended.
Development Consulting and Early Engagement Experts with deep therapeutic knowledge engage with clients before the study’s protocol is developed or advise on an existing protocol to limit amendments and reduce costs.
ACTIVATE AND ENROLL SITES FASTER PPD delivers studies on time with our proven trial optimization methodology. Our four-part approach results in high-level site enrollment and performance, and includes:
Oncology clinical trials represent a special challenge for biopharmaceutical companies. When oncology research sites enroll, it takes an average of more than eight months from protocol outreach to site activation. Some 60 percent of sites never enroll and 40 percent of ongoing trials never meet enrollment targets*.
* https://www.forbes.com/sites/judystone/2015/01/06/how-can-we-encourage-participation-in-clinical-trials/#1dc9f1ac4d0c
ONCOLOGY ENROLLMENT ENHANCEMENT THE JUST-IN-TIME APPROACH
Prestudy Just-in-Time 10-14 days
Community of sites with pre-negotiated
contracts/terms
Patients identified and site
activated
Patients enrolled within two weeks of identification
Immediate engagement by sites to search for patients
Oncology enrollment enhancement uses a just-in-time methodology
to jump-start study enrollment. We provide confirmed availability of
pre-identified patients from pre-qualified sites in our community of
over 300 sites with over 1,000 research-experienced investigators. This
turnkey service augments your traditional trial approach and provides
the first study subject within two weeks of patient identification.
Zero
non-enrolling sites in the just-in-time community
300+ pre-qualified sites
1,000+
investigators
Diversity Just-in-time sites are concentrated in ethnically diverse areas
Patient-centricExposing more trial options to patients while allowing sites to focus on studies for which they have patients
Efficiency Improved efficiencies/volume through protocol stacking
Performance Opportunity to accelerate overall study performance
Risk Management Mitigate risk from non-enrolling sites; risk mitigation strategy is available from day one
BENEFITS
linkedin.com/company/ppd
For more information, please contact us at
+1 877 643 8773 or +1 919 456 5600.
ppdi.com/oncology
© 2019 Pharmaceutical Product Development, LLC. All rights reserved. 05.2019
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